Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4 E): the ALIC4 E protocol

被引:21
|
作者
Bongard, Emily [1 ]
van der Velden, Alike W. [2 ]
Cook, Johanna [1 ]
Saville, Ben [3 ,4 ]
Beutels, Philippe [5 ]
Aabenhus, Rune Munck [6 ]
Brugman, Curt [2 ]
Chlabicz, Slawomir [7 ]
Coenen, Samuel [8 ,9 ]
Colliers, Annelies [8 ]
Davies, Melanie [10 ]
De Paor, Muireann [11 ]
De Sutter, An [12 ]
Francis, Nick A. [13 ]
Glinz, Dominik [14 ,15 ]
Godycki-cwirko, Maciek [16 ]
Goossens, Herman [9 ]
Holmes, Jane [17 ]
Ieven, Margareta [9 ]
de Jong, Menno [18 ]
Lindbaek, Morten [19 ]
Little, Paul [20 ]
Martinon-Torres, Frederico [21 ]
Moragas, Ana [22 ]
Pauer, Jozsef [23 ]
Pfeiferova, Marketa [24 ]
Radzeviciene-Jurgute, Ruta [25 ]
Sundvall, Paer-Daniel [26 ,27 ]
Torres, Antoni [28 ,29 ]
Touboul, Pia [30 ,31 ]
Varthalis, Dionyssios [32 ]
Verheij, Theo [2 ]
Butler, Christopher C. [1 ]
机构
[1] Univ Oxford, Nuffield Dept Primary Care Hlth Sci, Oxford, England
[2] Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands
[3] Berry Consultants, Austin, TX USA
[4] Vanderbilt Univ, Sch Med, Dept Biostat, Nashville, TN 37212 USA
[5] Univ Antwerp, Vaccine & Infect Dis Inst VAXINFECTIO, CHERMID, Antwerp, Belgium
[6] Univ Copenhagen, Inst Publ Hlth, Copenhagen, Denmark
[7] Med Univ Bialystok, Dept Family Med & Community Nursing, Bialystok, Poland
[8] Univ Antwerp, Ctr Gen Practice, Dept Primary & Interdisciplinary Care ELIZA, Antwerp, Belgium
[9] Univ Antwerp, Lab Med Microbiol, Vaccine & Infect Dis Inst VAXINFECTIO, Antwerp, Belgium
[10] Ely Bridge Surg, Ely, England
[11] Ireland Sch Med, Dept Gen Practice, Royal Coll Surg, Dublin, Ireland
[12] Univ Ghent, Dept Family Med & Primary Hlth Care, Ghent, Belgium
[13] Cardiff Univ, Sch Med, Dept Populat Med, Cardiff, S Glam, Wales
[14] Univ Basel, Basel, Switzerland
[15] Univ Hosp Basel, Basel Inst Clin Epidemiol & Biostat, Basel, Switzerland
[16] Med Univ Lodz, Dept Family & Community Med, Lodz, Poland
[17] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Ctr Stat Med, Oxford, England
[18] Acad Med Ctr, Dept Med Microbiol, Amsterdam, Netherlands
[19] Univ Oslo, Inst Hlth & Soc, Dept Gen Practice, Oslo, Norway
[20] Univ Southampton, Primary Care & Populat Sci, Southampton, Hants, England
[21] Univ Santiago de Compostela, Hosp Clin, SERGAS, Santiago De Compostela, Spain
[22] Univ Rovira & Virgili, Primary Healthcare Ctr Jaume 1, Tarragona, Catalonia, Spain
[23] Drug Res Ctr LLC, Balatonfured, Hungary
[24] Charles Univ Prague, Fac Med 1, Inst Gen Practice, Prague, Czech Republic
[25] JSC Mano Seimos Gydytojas, Klaipeda, Lithuania
[26] Res & Dev Ctr Sodra Alvsborg, Narhalsan, Res & Dev Primary Hlth Care, Boras, Sweden
[27] Univ Gothenburg, Sahlgrenska Acad, Dept Publ Hlth & Community Med, Gothenburg, Sweden
[28] Univ Barcelona, Hosp Clin Barcelona, Dept Pulmonol, Barcelona, Spain
[29] IDIBAPS, Barcelona, Spain
[30] Univ Hosp Nice, Dept Publ Hlth, Nice, France
[31] Univ Cote dAzur, Dept Teaching & Res Gen Practice, Nice, France
[32] Univ Crete, Clin Social & Family Med, Iraklion, Greece
来源
BMJ OPEN | 2018年 / 8卷 / 07期
关键词
influenza; oseltamivir; primary healthcare; cost-benefit analysis; adaptive clinical trial; PRESCRIBING STRATEGIES; RECOMMENDATIONS; SURVEILLANCE; OSELTAMIVIR;
D O I
10.1136/bmjopen-2017-021032
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies. Methods and analysis Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5days. We aim to recruit at least 2500 participants 1year presenting with influenza-like illness (ILI), with symptom duration 72hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (<12, 12-64 and >64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (48hours/>48-72hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms. Ethics and dissemination Research ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations.
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页数:11
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